VOLUME 46, ISSUE 12
ISSUE DATE: JUNE 16, 2014
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
BOARD OF PHARMACY
Proposed Amendment: N.J.A.C. 13:39-5.8
Minimum Standards for Container Integrity
Authorized By: State Board of Pharmacy, Anthony Rubinaccio, Executive Director.
Authority: N.J.S.A. 45:14-47 and 48.
Proposal Number: PRN 2014-084.
Submit written comments by August 15, 2014, to:
Anthony Rubinaccio, Executive Director
Board of Pharmacy
124 Halsey Street
PO Box 45013
Newark, New Jersey 07101
The agency proposal follows:
The Board of Pharmacy (Board) proposes amending N.J.A.C. 13:39-5.8(a)12 to specifically reference Chapters 661 and 671 of the United States Pharmacopoeia/National Formulary (USP) to provide licensees with clearer guidance about the minimum standards for container integrity. USP is the public standard-setting authority for prescription and over-the-counter products and often serves as a reference for the state boards. USP's drug standards are enforceable in the United States by the Food and Drug Administration.
Existing N.J.A.C. 13:39-5.8(a)12 provides the minimum standard for container integrity by referring broadly to the standards of the USP on light resistance and tightness. The Board proposes amending the provision to specifically incorporate by reference, as amended and supplemented, both the standards on light resistance, tightness, and water vapor permeation contained in Chapter 661 and of moisture permeability contained in Chapter 671 of the USP, 2014 edition. The Board believes that adding references to the standards of water vapor permeation and moisture permeability further clarifies the existing standard for container tightness. By USP definition, a tight container protects the contents from contamination by extraneous liquids, solids, or vapors; from loss of the article; and from efflorescence, deliquescence, or evaporation under the ordinary or customary conditions of handling, shipment, storage, and distribution; and is capable of tight reclosure.
Container integrity is necessary to maintain a drug product's quality throughout its shelf life. If container integrity is breached, there is risk that the drug might lose its potency or that it might absorb material from the container that is harmful to the patient. Because not all supplier products meet USP standards for container integrity and there may be price incentives for choosing suppliers, it is important for pharmacists to know the standards that must be met to ensure product integrity and patient safety. This specification of the USP chapters will provide licensees with clearer guidance, so that they can make informed decisions when choosing a container supplier and determining the container they should procure to dispense medications.
N.J.A.C. 13:39-5.8(a)11 is proposed for amendment to delete the cross-reference to the Department of Health's rules at N.J.A.C. 8:71-1, as Chapter 71 expired on November 13, 2009.
The Board has provided a 60-day comment period for this notice of proposal, therefore, this notice is excepted from the rulemaking calendar requirement pursuant to N.J.A.C. 1:30-3.3(a)5.
The Board of Pharmacy believes that the proposed amendment will have a positive impact upon pharmacists by providing clearer guidance as to the minimum standards prescription containers must meet. The Board also believes that the proposed amendment will have a positive social impact on the patients served by pharmacists in this State because the paragraph sets forth clear standards designed to promote patients' health and safety by ensuring the integrity and safety of prescription containers.
The Board of Pharmacy does not believe that the proposed amendment, which incorporates by reference, as amended and supplemented, the specific citation to USP chapters, will have an economic impact on licensees. Licensed pharmacists are currently required to comply with the standards of the USP on prescription container light resistance and tightness. The proposed amendment does not change these standards but rather provides licensees with clearer guidance. However, if pharmacies are using substandard containers, then some additional costs will be incurred by those pharmacies to comply with the regulation to ensure the safety of the drugs being dispensed to the public.
Federal Standards Statement
A Federal standards analysis is not required because the proposed amendment does not exceed, but rather references the standard and requirements set forth in the USP, which may be viewed as establishing and setting forth Federally enforceable standards and requirements for container integrity.
[page=1414] Jobs Impact
The Board does not anticipate that the proposed amendment will increase or decrease jobs in the State.
Agriculture Industry Impact
The proposed amendment will have no impact on the agriculture industry in the State.
Regulatory Flexibility Statement
The proposed amendment applies to all licensed pharmacists and pharmacies in the State, some of which may operate as "small businesses" within the meaning of the Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq. As the proposed amendment will impose no new costs or reporting, recordkeeping, or compliance requirements, and as the Board does not believe that licensees will need to employ any professional services to comply with the proposed amendment, a regulatory flexibility analysis is not required.
Housing Affordability Impact Analysis
The proposed amendment will have an insignificant impact on affordable housing in New Jersey and there is an extreme unlikelihood that the proposed amendment would evoke a change in the average costs associated with housing because the proposed amendment concerns standards for prescription container integrity.
Smart Growth Development Impact Analysis
The proposed amendment will have an insignificant impact on smart growth and there is an extreme unlikelihood that the proposed amendment would evoke a change in housing production in Planning Areas 1 or 2, or within designated centers, under the State Development and Redevelopment Plan in New Jersey because the proposed amendment concerns standards for prescription container integrity.
Full text of the proposal follows (additions indicated in boldface thus; deletions indicated in brackets [thus]):
SUBCHAPTER 5. RETAIL FACILITY REQUIREMENTS
13:39-5.8 Minimum equipment and supplies; cleanliness
(a) All prescription areas shall contain the following minimum equipment and supplies, which shall be stored, so as to be readily accessible:
1.-10. (No change.)
11. Two Drug Utilization Review Council Placards and the 29th edition of the list of "Approved Drug Products with Therapeutic Equivalence Evaluations," commonly known as the "Orange Book," incorporated herein by reference, as amended and supplemented[, consistent with Department of Health and Senior Services rules set forth at N.J.A.C. 8:71-1]. The Orange Book can be obtained by contacting the Superintendent of Documents, Government Printing Office, PO Box 371954, Pittsburgh, PA 15250-7954, (202) 512-1800 or toll free (866) 512-1800, and is available on-line at http://www.fda.gov/cder/orange/default.htm and at http://www.fda.gov/cder/ob/default.htm;
12. Assorted stock of prescription containers and child safety closures or caps that meet the standards on light resistance, tightness, and water vapor permeation of Chapter 661 and moisture permeability of Chapter 671 of the United States Pharmacopoeia/National Formulary [standards on light resistance and tightness], 2014 edition, which are both incorporated herein by reference, as amended and supplemented, and are available for purchase at the United States Pharmacopeia/National Formulary website at www.usp.org; and
13. (No change.)
(b)-(c) (No change.)